Quality Assurance Assistant - Compliance
Althea Technologies - San Diego, CA

This job posting is no longer available on Indeed. Find similar jobs: Quality Assurance Assistant jobs - Althea Technologies jobs

If you meet the requirements above and would like to apply for this position, please visit our website at www.atheatech.com and click on the ‘Careers’ section.

Be Part of a Growing and Innovative Organization!

Althea Technologies is currently seeking a Quality Assurance Associate-Compliance. This position is responsible for performing a wide variety of semi-routine, moderately complex activities pertaining to assuring compliance with applicable regulatory requirements, including assisting with internal audits, customer audits, external audits, preventive action programs, deviation programs, training programs, and documentation review.

ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:

  • Facilitates the internal audit program

o Schedules and conducts comprehensive GMP internal audits in accordance with written procedures to verify the adequacy and effectiveness of procedures and processes
o Develops detailed internal audit plans
o Prepares detailed written audit reports
o Assists in developing recommendations for internal audit corrective actions/improvements and establishing timelines
o Maintains an efficient internal audit observation and corrective action tracking system
o Performs corrective action follow-ups ensuring timely completion of corrective actions
o Evaluates the effectiveness of corrective actions
o Performs regular walk-through audits of the GMP areas

  • Supports the customer audit process

o Hosts customer audits
o Prepares document requests in accordance with customer audit agendas
o Collaborates with internal departments to ensure effective customer audit responses/corrective actions are generated in a timely manner
o Performs corrective action follow-ups to ensure that commitments to our clients are completed as agreed in the customer audit response

  • Assists with external audit processes
  • Develops detailed audit plans in accordance with approved procedures
  • Conducts comprehensive GMP audits of suppliers
  • Prepares detailed written reports for supplier audits

o Performs corrective action follow-ups and tracking of corrective actions

  • Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis
  • Interacts with clients and follows up on client inquiries
  • Writes detailed reports and analyzes quality data
  • Generates quality systems metrics for management review. Reviews data obtained for compliance specifications and report abnormalities
  • Assists with management of electronic quality management system processes.

EDUCATION AND EXPERIENCE:

  • Bachelor’s degree in a Life Sciences discipline or equivalent
  • Minimum four (4) years of relevant experience in auditing, documentation, quality assurance or equivalent
  • Knowledge of GLP and cGMP regulations and good documentation practices
  • Detail oriented with strong written and verbal communication skills
  • Ability to work independently, within prescribed guidelines, or as a team member
  • Demonstrated ability to follow detailed directions in a laboratory environment
  • Strong organizational and analytical skills
  • Must be familiar with Microsoft Office applications

If you meet the requirements above and would like to apply for this position, please visit our website at www.atheatech.com and click on the ‘Careers’ section.

Althea Technologies, located in San Diego, CA, is a contract development and manufacturing organization that specializes in cGMP manufacturing, analytical development, aseptic filling into vials & syringes, and protein delivery technology for recombinant protein and parenteral products. In a single location, Althea has the experience, expertise, capacity, and flexibility to serve as a strategic partner for drug development and manufacturing needs for early- stage and commercial requirements.

Althea is an EOE dedicated to a diverse work force and Drug Free work environment.
Qualified M/F/D/V candidates are encouraged to apply.


Indeed - 22 months ago - save job - copy to clipboard
About this company
4 reviews
Ajinomoto Althea, Inc., located in San Diego, CA, is a contract development and manufacturing organization that specializes in cGMP...